Catalog Number 190305 |
Device Problems
Mechanical Problem (1384); Reflux within Device (1522)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/20/2022 |
Event Type
malfunction
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Event Description
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A biomedical technician (biomed) at a user facility reported that a fresenius 2008k hemodialysis (hd) machine had a saline bag backfill during set-up for use.The biomed stated that the backfill occurs when the dialyzer is connected.The biomed did not report that there were any machine alarms.A patient was not connected to the machine at the time of the incident.The biomed performed troubleshooting on the machine during the call with fresenius technical services at which point transmembrane pressure (tmp) also measured positive.The biomed ordered a replacement flow pump to resolve the reported issues.Additional information was requested, however a response was not received.No parts were returned to the manufacturer for a physical evaluation.
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Manufacturer Narrative
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The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
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Manufacturer Narrative
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Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
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Event Description
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A biomedical technician (biomed) at a user facility reported that a fresenius 2008k hemodialysis (hd) machine had a saline bag backfill during set-up for use.The biomed stated that the backfill occurs when the dialyzer is connected.The biomed did not report that there were any machine alarms.A patient was not connected to the machine at the time of the incident.The biomed performed troubleshooting on the machine during the call with fresenius technical services at which point transmembrane pressure (tmp) also measured positive.The biomed ordered a replacement flow pump to resolve the reported issues.Additional information was requested, however a response was not received.No parts were returned to the manufacturer for a physical evaluation.
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Search Alerts/Recalls
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